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临床试验/NCT05649124
NCT05649124已完成不适用

The Effect of Acupressure on Perineal Pain Level in Primiparous Women With Episiotomy: A Randomized Controlled Study

Kocaeli University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
VAS (Visual analog scale) Evaluation of Perineal Pain

研究概览

简要总结

The study is a randomized controlled study to evaluate the effectiveness of acupressure applied to primiparous pregnant women who underwent episiotomy in the early postpartum period.

The research was carried out between August 2022 and November 2022 at Düzce University Health Practice and Research Center with mothers who gave vaginal birth. The research was carried out with two groups as acupressure and control groups. The sample number was calculated using the G*Power 3.1.9.2 program and the acupressure group: 30 and the control group: 30. It was collected the research data with the Introductory Information Form and Visual Analog Scale. The participants in the acupressure group were interviewed at the 3rd and 5th hours after birth. The application announcement was made and they were allowed to sign the voluntary consent form. The VAS was filled by the participant before the application. Acupressure was applied to SP6, ST36 and LI4 points for a total of 12 minutes. After the application, the VAS was filled again by the participant.

No application was made to the control group. The data of the research was evaluated using the Statistical Package 22.0 program for Social Sciences. In the evaluation of the data; descriptive statistics was given as percentage, arithmetic mean±standard deviation, median and minimum-maximum values. Independent two-sample t-test was used for normally distributed variables and Mann-Whitney U test was used for non-normally distributed variables. Pearson Correlation test was applied to determine the relationship between the pain intensity of the acupressure group and the tests and to determine the relationship between the tests. Statistical significance level was accepted as p<0.05.

详细描述

Aim: This study was planned to examine the effect of acupuncture on perineal pain after episiotomy in the early postpartum period.

Research hypothesis:

H0: Acupressure application applied to pregnant women who underwent episiotomy in the postpartum period has no effect on reducing the level of perineal pain.

H1: Acupressure application applied to pregnant women who underwent episiotomy in the postpartum period reduces the level of perineal pain.

Type of Study: This study was designed as a randomized controlled experimental study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elementary school or higher education
  • 18 years and over,
  • Primiparous,
  • Episiotomy was applied,
  • Having a normal delivery in the hospital where the study was conducted,
  • Able to speak and understand Turkish,
  • No medical treatment to affect the pain,
  • Perineal pain score is above 4 according to VAS (Visual analog scale),
  • Participants who voluntarily agree to participate in the study will be included in the study.

排除标准

  • Does not have sufficient mental health to fill out the questionnaire,
  • Experiencing postpartum complications (bleeding, infection, etc.),
  • With impaired tissue integrity in the area to be applied,
  • Having genital infection
  • Heir in perineum,
  • Taking painkillers in the last 6 hours,
  • Smoking or using alcohol
  • Pharmacological and non-pharmacological intervention to reduce postpartum perineal pain,
  • Excluding episiotomy in a different region of the perineum, In addition, those who want to leave the research at any stage of the research will be excluded from the research.

结局指标

主要结局

VAS (Visual analog scale) Evaluation of Perineal Pain

时间窗: It was applied to evaluate perineal pain just before the application of acupressure at the 5th hours postpartum.

The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement. The VAS is more sensitive than the simple descriptive scale.

次要结局

  • VAS (Visual analog scale) Evaluation of Perineal Pain(It was applied to evaluate perineal pain immediately after acupressure application at the postpartum 5th hour.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sena dilek

Principal Investigator

Kocaeli University

研究点 (2)

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